CMDE seeks feedback on trial exempt devices



The Center for Medical Device Evaluation (CMDE) released “Added and Updated Medical Devices Exempted for Clinical Trials in 2020 (draft proposal)”, open for public feedback until August 31. A total of 34 Category II and 19 Category III devices are new entrants, including foraminal mirror, metal interlocking intramedullary nail, infant incubator and others.

Another 9 Category II and 2 Category III devices have their product descriptions revised, while 15 in vitro diagnostic (IVD) reagents are now exempt from clinical studies, including 7 for enzyme detection, 2 for allergies, and 1 each for hormone testing, ester, and autoantibody.

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